National Health Act 1953 Amendment declaration under subsections 85(2) and 85(2AA) Amendment determination under subsection 85(2A) drugs and medicinal preparations (No. PB 78 of 2007) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 78 of 2007

Amendment declaration under subsections 85(2) and 85(2AA) of the National Health Act 1953

Amendment determination under subsection 85(2A) of the National Health Act 1953

I, STEPHEN DELLAR, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, make this instrument under subsections 85 (2), 85(2A) and 85(2AA) of the National Health Act 1953.

Dated 2 October 2007

STEPHEN DELLAR

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment declaration and determination — drugs and medicinal preparations

1 Commencement

This instrument commences on 1 November 2007.

2 Amendment of PB 48 of 2007

Schedule 1 amends PB 48 of 2007.

Schedule 1 Amendments

[1] Schedule 1, item dealing with Amino acids — synthetic, formula

omit from the columns indicated:

In compliance with authority procedures set out in subparagraph 14 (d):

Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula, and where the date of birth of the patient is included in the authority application

Continuing treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application

Treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged 2 years or over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application

Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed

Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition

and substitute:

In respect of the oral powder 400 g (EleCare):

In compliance with authority procedures set out in subparagraph 14 (d):

Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed

Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition

Initial treatment for up to 3 months, by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who requires an amino acid based formula as a component of a dietary elimination programme, and where:

eosinophilic oesophagitis is demonstrated by the following criteria:

(i) chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and

(ii) a lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and

(iii) eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy specimen had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies;

the date of birth of the patient is included in the authority application;

treatment with oral steroids is not commenced during the period of initial treatment

Continuing treatment by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who has responded to a initial course of PBS-subsidised treatment, and where:

response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy specimen has 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies;

the response criteria will be deemed to have been not met if the patient commenced oral steroids during initial treatment

In respect of the oral powder 400 g (Neocate), oral powder 400 g (Neocate Advance) and oral powder 400 g (Neocate Advance Tropical Flavour):

In compliance with authority procedures set out in subparagraph 14 (d):

Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed

Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition

[2] Schedule 1, after item dealing with Bleomycin

insert in the columns in the order indicated:

Bortezomib	In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Continuing PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid, of multiple myeloma in a patient who has previously received 8 treatment cycles with bortezomib and who, at the time of application, has demonstrated at least a partial response to bortezomib but who has not received 2 treatment cycles after first achieving a confirmed complete response; and
where the following conditions apply:
if serum M protein and urine Bence-Jones protein levels are measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as:
(a) at least a 50% reduction in the level of serum M protein (monoclonal protein); or
(b) at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours;
if serum M protein and urine Bence-Jones protein levels are unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as:
(c) the difference between involved and uninvolved serum free light chain (FLC) levels, with at least a 50% reduction in this value;
if serum M protein and urine Bence-Jones protein levels and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(d) at least a 50% reduction in bone marrow plasma cells; or
(e) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L; or
(f) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(g) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. magnetic resonance imaging or computed tomography scan);
the same parameters provided for the diagnosis of progressive disease are used to demonstrate at least a partial response to treatment;
a patient is eligible for continuing PBS-subsidised bortezomib treatment beyond 8 cycles if they have achieved at least a partial response at the completion of cycle 8, and the results of the response assessment are included in the application for authorisation of further treatment;
a patient will be deemed to have failed to respond to 8 cycles of treatment with bortezomib, despite demonstrating a partial response, if the response assessment is not submitted to the Medicare Australia CEO prior to cycle 9;
the authority application is made not later than 10 months after the application for initial treatment and includes:
(1) a completed copy of the appropriate Multiple Myeloma Authority Application - Supporting Information Form; and
(2) diagnostic reports, which are no more than 1 month old at the time of application, demonstrating that the patient has achieved at least a partial response;
a patient is eligible to receive no more than 2 cycles of treatment beyond the cycle at which a complete response, confirmed by 2 determinations a minimum of 6 weeks apart, was first achieved;
PBS-subsidised treatment with bortezomib is limited to a maximum of 11 cycles
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial PBS-subsidised treatment of multiple myeloma in patients receiving treatment with bortezomib prior to 1 November 2007; and
where the following conditions apply:
patients who fail to demonstrate at least a partial response after 4 cycles are not eligible to receive further PBS-subsidised treatment with bortezomib;
patients who qualify for PBS-subsidised treatment under this restriction may receive a maximum of 3 cycles, after which the patient must qualify under the continuing treatment criteria to receive further treatment;
the authority application includes:
(1) a completed copy of the appropriate Multiple Myeloma Authority Application - Supporting Information Form; and
(2) a signed patient acknowledgment; and
(3) details including relevant reports of the basis of the diagnosis of progressive disease and nomination of which disease activity parameters will be used to assess response; and
(4) if relevant, details including relevant reports for patients who have demonstrated a partial response and who have received 4 or more cycles;
diagnostic reports demonstrating at least a partial response are within 1 month of the date of application
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid, of multiple myeloma in a patient with a World Health Organisation (WHO) performance status of 2 or less, who has progressive disease, who has received at least 1 prior therapy (other than thalidomide), who has undergone or is ineligible for a primary stem cell transplant and who has experienced treatment failure after a trial of at least 4 weeks of thalidomide at a dose of at least 100 mg daily; and
where the following conditions apply:
if the dosing requirement for thalidomide cannot be met, the authority application states the reasons why this criterion cannot be satisfied;
thalidomide treatment failure is defined as:
(1) confirmed disease progression during or within 6 months of discontinuing thalidomide treatment; or
(2) severe intolerance or toxicity unresponsive to clinically appropriate dose adjustment;
progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(d) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(e) at least a 25% increase in the size of an existing, or the development of a new, soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(f) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause);
severe intolerance due to thalidomide is defined as unacceptable somnolence or sedation interfering with activities of daily living;
toxicity from thalidomide is defined as peripheral neuropathy (Grade 2 or greater, interfering with function), drug-related seizures, serious Grade 3 or Grade 4 drug-related dermatological reactions, such as Stevens-Johnson Syndrome, or other Grade 3 or 4 toxicity;
the authority application includes:
(1) a completed copy of the appropriate Multiple Myeloma Authority Application - Supporting Information Form, which includes details of prior treatments including names of drugs and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; the patient's WHO performance status; details of thalidomide treatment failure; details of the basis of the diagnosis of progressive disease; nomination of which disease activity parameters will be used to assess response; and the results of current diagnostic reports as detailed below; and
(2) duration of thalidomide and daily dose prescribed; and
(3) a signed patient acknowledgment;
to enable the Medicare Australia CEO to confirm response, current diagnostic reports of the following are required to establish baseline:
(a) the level of serum M protein (monoclonal protein); and
(b) if Bence-Jones proteinuria is present, the results of 24-hour urinary light chain M protein excretion;
if neither serum M protein nor urine Bence-Jones protein is present in measurable quantities, additional diagnostic reports are required, including:
(c) bone marrow aspirate and trephine; and
(d) if present, the size and location of lytic bone lesions (not including compression fractures); or
(e) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination, i.e. magnetic resonance imaging or computed tomography scan; or
(f) if present, the level of hypercalcaemia, corrected for albumin concentration; or
(g) if present, the serum free light chain levels;
to enable assessment of response, baseline values for the above parameters must be provided with the authority application as follows:
(i) for all patients, results for (a) and (b) must be provided;
(ii) where the patient has oligo-secretory or non-secretory multiple myeloma, results for (c) and if relevant (d), (e) or (f) must be provided;
(iii) where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, results for (g) must be provided;
where baseline values for 1 or more of the specified parameters cannot be provided, the authority application states the reason or reasons these cannot be provided
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Continuing PBS-subsidised treatment, as monotherapy or in combination with a corticosteroid, of multiple myeloma in a patient who has previously received 4 treatment cycles of bortezomib and who, at the time of application, has demonstrated at least a partial response to bortezomib; and
where the following conditions apply:
if serum M protein and urine Bence-Jones protein levels are measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as:
(a) at least a 50% reduction in the level of serum M protein (monoclonal protein); or
(b) at least a 90% reduction in 24-hour urinary light chain M protein excretion or to less than 200 mg per 24 hours;
if serum M protein and urine Bence-Jones protein levels are unmeasurable as in non-secretory/oligo-secretory multiple myeloma, partial response compared with baseline is defined as:
(c) at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels;
if serum M protein and urine Bence-Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as:
(d) at least a 50% reduction in bone marrow plasma cells; or
(e) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L; or
(f) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or
(g) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. magnetic resonance imaging or computed tomography scan);
the same parameters provided for the diagnosis of progressive disease are used to demonstrate at least a partial response to treatment;
a patient is eligible for continuing PBS-subsidised bortezomib treatment beyond 4 cycles if they have achieved at least a partial response at the completion of cycle 4, and the results of the response assessment are included in the application for authorisation of further treatment;
a patient will be deemed to have failed to respond to 4 cycles of treatment with bortezomib, despite demonstrating a partial response, if the response assessment is not submitted to the Medicare Australia CEO prior to cycle 5;
the authority application is made not later than 6 months after the application for initial treatment and includes:
(1) a completed copy of the appropriate Multiple Myeloma Authority Application - Supporting Information Form; and
(2) diagnostic reports, which are no more than 1 month old at the time of application, demonstrating that the patient has achieved at least a partial response;
patients who fail to demonstrate at least a partial response after 8 cycles are not eligible to receive further PBS-subsidised treatment with bortezomib;
a patient is eligible to receive no more than 2 cycles of treatment beyond the cycle at which a complete response, confirmed by 2 determinations a minimum of 6 weeks apart, was first achieved

[3] Schedule 1, item dealing with Docetaxel

omit from the columns indicated:

In compliance with authority procedures set out in subparagraph 14 (d):

Adjuvant treatment of node-positive breast cancer in combination with an anthracycline and cyclophosphamide

Advanced breast cancer after failure of prior therapy which includes an anthracycline

Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound

Locally advanced or metastatic non-small cell lung cancer

Treatment of HER2 positive early breast cancer in combination with trastuzumab.

and substitute:

In compliance with authority procedures set out in subparagraph 14 (d):

Adjuvant treatment of node-positive breast cancer in combination with an anthracycline and cyclophosphamide

Advanced breast cancer after failure of prior therapy which includes an anthracycline

Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound

Locally advanced or metastatic non-small cell lung cancer

Treatment of HER2 positive early breast cancer in combination with trastuzumab

Treatment of androgen independent (hormone refractory) metastatic carcinoma of the prostate in a patient with a Karnofsky performance-status score of at least 60%, where docetaxel is used as first-line chemotherapy and administered in three weekly cycles

Treatment of androgen independent (hormone refractory) metastatic carcinoma of the prostate in a patient with a Karnofsky performance-status score of at least 60%, where the patient was receiving prior treatment with other chemotherapy for androgen independent (hormone refractory) metastatic carcinoma of the prostate at 1 November 2007, and where docetaxel is administered in three weekly cycles

[4] Schedule 1, item dealing with Efalizumab

omit the eight instances of the following words, in the column headed ‘Circumstances’:

systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin)

and substitute in all instances with:

systemic monotherapy (other than methotrexate)

and

omit the eight instances of the following words, in the column headed ‘Circumstances’:

systemic monotherapy,

and substitute in all instances with:

systemic monotherapy (other than methotrexate),

[5] Schedule 1, item dealing with Etanercept, for the circumstances regarding the treatment of chronic plaque psoriasis

omit the eight instances of the following words, in the column headed ‘Circumstances’:

systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin)

and substitute in all instances with:

systemic monotherapy (other than methotrexate)

and

omit the eight instances of the following words, in the column headed ‘Circumstances’:

systemic monotherapy,

and substitute in all instances with:

systemic monotherapy (other than methotrexate),

[6] Schedule 1, item dealing with Glucose Indicator—Blood

insert in alphabetical order in the column headed ‘Circumstances’:

electrode strips, 50 (Optium Omega),

[7] Schedule 1, after item dealing with Ifosfamide

insert in the columns in the order indicated:

Imatinib	In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial PBS-subsidised treatment, for up to 3 months, of adult patients with a metastatic or unresectable malignant gastrointestinal stromal tumour which has been histologically confirmed by the detection of CD117 on immunohistochemical staining; and
where the following conditions apply:
patients who have not previously been treated with imatinib mesylate for a metastatic or unresectable malignant gastrointestinal stromal tumour commence treatment at a dose that does not exceed 400 mg per day for at least 3 months;
patients who have previously been treated with non-PBS-subsidised imatinib mesylate for a metastatic or unresectable malignant gastrointestinal stromal tumour are eligible to receive up to 3 months treatment at a dose of up to 600 mg per day;
the application for authorisation includes a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following:
(i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and
(ii) a copy of the most recent (within 2 months of the application) computed tomography (CT) scan, magnetic resonance imaging (MRI) or ultrasound assessment of the tumour or tumours, including whether or not there is evidence of metastatic disease; and
(iii) where the application for authority to prescribe is being sought on the basis of an unresectable tumour, written evidence in support of that claim; and
(iv) for patients who commenced treatment with imatinib mesylate for a metastatic or unresectable malignant gastrointestinal stromal tumour prior to 1 December 2004, the date on which therapy with imatinib mesylate was commenced
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuing PBS-subsidised treatment, at a dose of up to 600 mg per day, of adult patients with a metastatic or unresectable malignant gastrointestinal stromal tumour who have previously been issued with an authority prescription for this drug
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment of patients in the chronic phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia; and
where the following conditions apply:
treatment under this restriction is limited to a maximum of 18 months of therapy from the date the first application for initial treatment is approved;
the application for authorisation includes:
(1) a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia - Supporting Information form; and
(2) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the bcr-abl transcript in either peripheral blood or bone marrow; and
(3) a copy of a signed patient acknowledgement form indicating that the patient understands and acknowledges that PBS-subsidised treatment with imatinib mesylate for the chronic phase of chronic myeloid leukaemia will cease if subsequent testing demonstrates that:
(i) the patient has failed to achieve a major cytogenetic response within the initial 18 months of treatment; or
(ii) the patient has failed to sustain a major cytogenetic response for 12 months from the date of the last pathology report that indicated that a major cytogenetic response had been achieved;
the patient is not receiving concomitant PBS-subsidised interferon alfa therapy
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Continuing treatment of patients who have received initial treatment with imatinib mesylate as a pharmaceutical benefit for the chronic phase of chronic myeloid leukaemia and who have demonstrated either a major cytogenetic response or less than 1% bcr-abl level in the blood in the preceding 12 months; and
where the following conditions apply:
a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells;
a peripheral blood bcr-abl level of less than 1% on the international scale (Blood 108: 28-37, 2006) indicates a response, at least the biological equivalent of a major cytogenetic response;
response to PBS-subsidised treatment with imatinib mesylate is assessed by:
(1) cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or, in the case where standard karyotyping is not informative for technical reasons, cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with bcr-abl specific probe; or
(2) quantitative PCR indicating the relative level of bcr-abl transcript in the peripheral blood using the international scale;
the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows:
(i) between 10 and 12 months of the commencement of treatment with imatinib mesylate, at which time patients in whom a major cytogenetic response or peripheral blood bcr-abl level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and
(ii) within 18 months of the commencement of treatment with imatinib mesylate, in patients who have failed to demonstrate a major cytogenetic response or peripheral blood bcr-abl level of less than 1% at between 10 and 12 months (at which time patients in whom a major cytogenetic response or peripheral blood bcr-abl level of less than 1% is demonstrable by 18 months are eligible for a further 12 months of treatment); and
(iii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood bcr-abl level of less than 1% has been sustained;
the authority application includes:
(1) demonstration of continued response to treatment as evidenced by:
(a) a copy of the cytogenetic analysis showing a major cytogenetic response, unless the relevant pathology report has been supplied within the previous 12 months, in which case only the date of this report need be provided; or
(b) a copy of the quantitative PCR analysis showing a peripheral blood level of bcr-abl of less than 1% on the international scale, unless the relevant pathology report has been supplied within the previous 12 months, in which case only the date of this report need be provided; and
(2) if the cytogenetic analysis submitted with the application was conducted using FISH with bcr-abl specific probe because standard karyotyping was not informative, a copy of the non-informative standard karyotype analysis;
a patient who has previously received PBS-subsidised treatment with imatinib mesylate and has at any time failed to meet the criteria for continuing treatment of chronic myeloid leukaemia in the chronic phase, is not eligible for PBS-subsidised re-treatment
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Treatment of patients in the accelerated phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia; and
where progress to the accelerated phase is defined by the presence of 1 or more of the following:
(1) percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or
(2) percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%; or
(3) peripheral basophils greater than or equal to 20%; or
(4) progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or
(5) karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); and
where the application for authorisation includes:
(a) a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia - Supporting Information form, stating which of the above criteria are satisfied by the patient; and
(b) a copy of the confirming pathology report from an Approved Pathology Authority in the case of criteria (1), (2), (3) and (5) above, or details of the dates of assessments in the case of progressive splenomegaly
In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Treatment of patients in the blast phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia; and
where progress to myeloid blast crisis is defined as either:
(1) percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or
(2) extramedullary involvement other than spleen and liver; and
where the application for authorisation includes:
(a) a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia - Supporting Information form, stating which of the above criteria are satisfied by the patient; and
(b) a copy of the confirming pathology report from an Approved Pathology Authority in the case of criterion (1) above, or details of the date of assessment in the case of extramedullary involvement
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuing treatment of patients with chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, where the patient has previously received PBS-subsidised treatment with imatinib mesylate of the accelerated phase of chronic myeloid leukaemia
In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Continuing treatment of patients with chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, where the patient has previously received PBS-subsidised treatment with imatinib mesylate of the blast phase of chronic myeloid leukaemia

[8] Schedule 1, item dealing with Milk powder — lactose free formula

omit from the columns indicated:

In compliance with authority procedures set out in subparagraph 14 (d):

Acute lactose intolerance in patients up to the age of 12 months, where the date of birth of the patient is included in the authority application and where the patient has not previously been issued with an authority prescription for this medicinal preparation for this purpose

Proven chronic lactose intolerance in patients up to the age of 12 months, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven either by the relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food, or by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet

and substitute:

In compliance with authority procedures set out in subparagraph 14 (d):

Acute lactose intolerance in infants up to the age of 12 months, where the date of birth of the patient is included in the authority application and where the patient has not previously been issued with an authority prescription for this medicinal preparation for this purpose

Proven chronic lactose intolerance in infants up to the age of 12 months, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven by:

(a) relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food; or

(b) not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet; or

[9] Schedule 1, item dealing with Milk powder — lactose modified

omit from the columns indicated:

In compliance with authority procedures set out in subparagraph 14 (d):

Acute lactose intolerance in children aged 1 year and over, where the date of birth of the patient is included in the authority application and where the patient has not previously been issued with an authority prescription for this medicinal preparation for this purpose

Proven chronic lactose intolerance in children aged 1 year and over who are significantly malnourished, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven either by the relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food, or by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet

and substitute:

In compliance with authority procedures set out in subparagraph 14 (d):

(a) relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food; or

(b) not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet; or

[10] Schedule 1, item dealing with Minoxidil

omit from the columns indicated:

In compliance with authority procedures set out in subparagraph 14 (d):

Severe refractory hypertension where treatment with minoxidil was initiated in a hospital (in-patient or out-patient)

1733

and substitute:

In compliance with authority procedures set out in subparagraph 14 (d):

Severe refractory hypertension where treatment is initiated by a consultant physician

2759

[11] Schedule 1, item dealing with Perindopril with Indapamide

omit from the columns indicated:

In respect of the tablet containing perindopril arginine 2.5 mg with indapamide hemihydrate 0.625 mg:

—

In respect of the tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg and tablet containing perindopril arginine 5 mg with indapamide hemihydrate 1.25 mg:

Hypertension in patients who are not adequately controlled with either indapamide hemihydrate or perindopril monotherapy

and substitute:

In respect of the tablet containing perindopril arginine 2.5 mg with indapamide hemihydrate 0.625 mg:

—

In respect of the tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg and tablet containing perindopril arginine 5 mg with indapamide hemihydrate 1.25 mg:

Hypertension in patients who are not adequately controlled with indapamide and/or perindopril

[12] Schedule 1, item dealing with Strontium

omit from the columns indicated:

In compliance with authority procedures set out in subparagraph 14 (d):

Treatment as the sole PBS-subsidised anti-resorptive agent for established post-menopausal osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body

2647

and substitute:

In compliance with authority procedures set out in subparagraph 14 (d):
2758	Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a woman aged 70 years or older with a bone mineral density T-score of -3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated
2647	Treatment as the sole PBS-subsidised anti-resorptive agent for established post-menopausal osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body

[13] Schedule 1, after item dealing with Tacrolimus

insert in the columns in the order indicated:

Tamarindus indica seed polysaccharide	In compliance with authority procedures set out in subparagraph 14 (d):
Tamarindus indica seed polysaccharide	1359	Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops

[14] Schedule 1, item dealing with Vancomycin

omit from the columns indicated:

In respect of the capsule 125 mg (125,000 I.U.) (as hydrochloride) and capsule 250 mg (250,000 I.U.) (as hydrochloride):

In compliance with authority procedures set out in subparagraph 14 (d):

Antibiotic associated pseudomembranous colitis due to Clostridium difficile which is unresponsive to metronidazole

Antibiotic associated pseudomembranous colitis due to Clostridium difficile where there is intolerance to metronidazole

In respect of the powder for injection 500 mg (500,000 I.U.) (as hydrochloride):

Prophylaxis of endocarditis in patients hypersensitive to penicillin

Endophthalmitis

Use initiated in a hospital for infections where vancomycin hydrochloride is an appropriate antibiotic

and substitute:

In respect of the capsule 125 mg (125,000 I.U.) (as hydrochloride) and capsule 250 mg (250,000 I.U.) (as hydrochloride):

In compliance with authority procedures set out in subparagraph 14 (d):

Antibiotic associated pseudomembranous colitis due to Clostridium difficile which is unresponsive to metronidazole

Antibiotic associated pseudomembranous colitis due to Clostridium difficile where there is intolerance to metronidazole

In respect of the powder for injection 500 mg (500,000 I.U.) (as hydrochloride) and powder for injection 1 g (1,000,000 I.U.) (as hydrochloride):

Prophylaxis of endocarditis in patients hypersensitive to penicillin

Endophthalmitis

Use initiated in a hospital for infections where vancomycin hydrochloride is an appropriate antibiotic

[15] Schedule 6, omit item dealing with Imatinib